High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
1 other identifier
interventional
10
1 country
2
Brief Summary
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2018
CompletedFirst Submitted
Initial submission to the registry
November 26, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2020
CompletedMay 27, 2020
May 1, 2020
10 months
November 26, 2018
May 22, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Effectiveness of the device for abdominal toning according to MRI images
Evaluation of MRI images before and after the therapy procedure.
7 months
Effectiveness of the device for abdominal toning according to waist circumference measurements
Evaluation of waist circumference measurements (in centimeters).
7 months
Secondary Outcomes (2)
Subject's satisfaction with study treatment: Questionnaire
7 months
Determination of side effects and adverse events (AE) associated with the study device.
7 months
Study Arms (1)
Treatment Group
EXPERIMENTALTreatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device
Interventions
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Eligibility Criteria
You may qualify if:
- Non-breastfeeding women 3-36 months after childbirth
- Voluntarily signed informed consent form
- BMI ≤ 30 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation
You may not qualify if:
- Cardiac pacemakers
- Implanted defibrillators, implanted neurostimulators
- Electronic implants
- Pulmonary insufficiency
- Metal implants
- Drug pumps
- Application in the head area
- Application in the heart area
- Malignant tumor
- Fever
- Pregnancy
- Breastfeeding
- Following recent surgical procedures when muscle contraction may disrupt the healing process
- Application over areas of the skin which lack normal sensation
- Scars, open lesions and wounds at the treatment area
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Skin Care Physicians of Georgia
Macon, Georgia, 31217, United States
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2018
First Posted
November 29, 2018
Study Start
October 25, 2018
Primary Completion
August 13, 2019
Study Completion
January 2, 2020
Last Updated
May 27, 2020
Record last verified: 2020-05